More than two weeks after Pfizer (NYSE: PFE) and Novo Nordisk (NASDAQ Copenhagen: NOVO-B) slugged it out for Metsera (NASDAQ: MTSR), biopharma found itself in the grip of another bidding war.
This latest corporate clash has Alkermes (NASDAQ: ALKS) working to beat back a challenge from H. Lundbeck (NASDAQ Copenhagen: HLUN-A and HLUN-B) for sleep disorder drug developer Avadel Pharmaceuticals (NASDAQ: AVDL).
Avadel’s investors emerged this past week as the early winners, as the company’s stock has surged 29% over the past month and more than doubled, zooming 152% since May. Over the past week, Avadel jumped 22.5% to $23.56 on November 14 on news of Lundbeck’s counteroffer, but finished this week dipping 2% to $23.03.
Those leaps began days before Avadel’s October 22 announcement that it agreed to be acquired by Alkermes for up to approximately $2.1 billion. Both Alkermes and Avadel are based in Dublin, Ireland, and also have operations in the United States. Like the original Pfizer-Metsera announcement, Avadel-Alkermes looked to be a cut-and-dry buyout deal.
That changed on November 14, when Copenhagen-based Lundbeck, which specializes in neurological and psychiatric disease drugs, emerged to outbid Alkermes with an offer of up to approximately $2.4 billion for Avadel. Not surprisingly, Avadel’s board responded three days later by declaring the Lundbeck offer to be a “company superior proposal,” which gave Alkermes five days to match or top Lundbeck’s offer.
In response, Alkermes raised its offer for Avadel, bringing it up to approximately $2.37 billion. Avadel‘s board then declared the revised Alkermes bid a “company superior proposal.”
Why did Avadel’s board switch its judgment of superiority to Alkermes’ second offer when Lundbeck offered potentially more money? Avadel offered an explanation in a regulatory filing on Wednesday:
“The board of directors of Avadel determined that while the upfront cash consideration of $21.00 per share in Alkermes’ Increased Offer is identical to the cash consideration proposed in the Lundbeck Proposal, the terms of the CVR in Alkermes’ Increased Offer are superior to the terms of the CVR included in the Lundbeck Proposal, which was determined to be unlikely to be achieved,” Avadel concluded.
Lundbeck’s next move was not known at deadline.
Lundbeck stock yo-yoed this past week, finishing Friday with a 4% dip for “A” shares to DKK 33.50 ($5.16) from DKK 34.80 ($5.36) a week earlier. “B” shares slid 3% to DKK 44.18 ($6.81) on Friday from DKK 45.52 ($7.02) on November 14.
Lundbeck’s A shares offer investors 10 votes per share, compared with one vote per B share. The A shares have fallen 5% from DKK 35.40 ($5.46) over the past month but risen 10% from DKK 30.55 ($4.71) over six months, while B shares have declined 4% from DKK 45.88 ($7.07) on October 21 but increased 20% from DKK 36.88 ($5.68) on May 21.
Alkermes shares rose 1.5% Friday to $28.61, but finished the week mostly flat, sliding 1.5% from $29.04 a week earlier. Shares have fallen 9% month over month from $31.45 and dropped 6% from $30.53 over six months.
Upfront cash, CVR combinations
Both Alkermes and Lundbeck proposed combinations of upfront cash and contingent value rights (CVR) payable upon achieving one or more milestones.
Alkermes initially offered $20 a share cash, consisting of $18.50 per share upfront payable at deal closing, plus a CVR entitling Avadel shareholders to $1.50 per share, tied to achieving final FDA approval of Lumryz for the treatment of idiopathic hypersomnia in adults by the end of 2028.
Lundbeck countered with $23 per share—$21 per share upfront, CVR of up to $2 per share, consisting of:
$1 per share if Lumryz and valiloxybate together reach total annual net sales for end-use in the United States of at least $450 million in any calendar year by December 31, 2027.
$1 per share if Lyumryz and valiloxybate collectively reach at least $700 million in total annual net sales in the United States in any calendar year by December 31, 2030.
Valiloxybate is a GABAB receptor agonist that Avadel is developing under an exclusive global license agreement with XWPharma covering all indications, including sleep disorders such as narcolepsy and idiopathic hypersomnia. Avadel agreed in return to pay XWPharma $20 million upfront, up to $30 million tied to achieving development milestones, $155 million if annual net sales reach up to $750 million, and 10% of annual sales exceeding $750 million up to $3.5 billion.
Alkermes’ second offer amounted to $22.50 per share, consisting of $21 per share cash, plus its original $1.50 per share CVR provision tied to final FDA approval of Lumryz for idiopathic hypersomnia in adults by the end of 2028.
“We think there is a non-zero chance Lundbeck could sweeten its offer,” Andrew Tsai, equity analyst with Jefferies, wrote in a research note.
“Persistent interest”
“We could argue Lundbeck has shown signs of persistent interest in AVDL,” Tsai added, if, as he surmised, Lundbeck was the unnamed “Party A” that was the one other serious bidder for Avadel, according to a November 13 regulatory filing detailing how Alkermes decided to acquire the company.
According to that filing, Alkermes made an initial offer of about $1.27 billion for Avadel ($12.50 per share) in July, six months after initially discussing a clinical development partnership. Alkermes signed a nondisclosure agreement a month later, “to facilitate the parties continuing their ongoing discussions regarding Avadel’s programs and potential business development opportunities.”
Lundbeck’s counteroffer for Avadel came just days after the company reported strong third-quarter results. Lundbeck finished the first nine months of 2025 with earnings before adjusted interest, taxes, depreciation, and amortization (EBITDA) of DKK 6.727 billion ($1.037 billion), up 21% from DKK 5.196 billion ($801.01 million) in Q1–Q3 2024, on revenue that rose 13% year-over-year, to DKK 18.537 billion ($2.858 billion) from DKK 16.463 billion ($2.538 billion).
Adjusted EBITDA excludes depreciation and amortization, impairment losses and reversals of impairment losses, as well as adjustments restricted to integration expenses, restructuring expenses, gains/losses on divestment of businesses, acquisition expenses, and other adjustments.
Alkermes saw its adjusted EBITDA tumble 16% during the first nine months of 2025, to $293.658 million from $351.406 million in Q1–Q3 2024, on total revenues that slid 3% year over year to $1.091 billion from $1.128 billion.
Avadel, by contrast, finished January–September 2025 with net income of $4.765 million, reversing its year-ago net loss of $43.789 million, thanks to a 67% jump in net product revenue, to $189.107 million from $118.707 million in Q1–Q3 2024. During the third quarter, Avadel racked up $20,000 in net income, compared with a $2.625 million net loss in Q3 2024, on net product revenue that rose 55% year-over-year to $77.467 million from $50.025 million.
Agios falls 50% on Phase III SCD data
Agios Pharmaceuticals (NASDAQ: AGIO) shares lost more than half their value on Wednesday, after the company reported mixed data from its Phase III RISE UP trial (NCT05031780) assessing its sickle cell disease candidate mitapivat, while maintaining it was still on track to pursue FDA approval for its supplemental New Drug Application (sNDA) next year.
Mitapivat, now marketed as a hemolytic anemia treatment under the name Pyrukynd®, failed part of the RISE UP trial by delivering a reduced annualized rate of sickle cell pain crises (SCPCs) compared with placebo, which was not statistically significant—2.62 vs. 3.05. SCPCs are defined as acute pain needing medical contact, acute chest syndrome, priapism, hepatic, or splenic sequestration.
Mitapivat also missed one of three key secondary efficacy endpoints, by not showing statistical significance in Week 24 through Week 52 average change from baseline on Patient Reported Outcome Measurement Information System Fatigue 13a (PROMIS Fatigue). The average change from baseline in PROMIS Fatigue score was -2.72 in the mitapivat arm vs -2.25 in the placebo arm. Negative change from baseline scores indicates improvements in fatigue.
However, mitapivat achieved statistically significant improvement in a second primary endpoint, hemoglobin response, with 40.6% of mitapivat patients achieving a ≥1.0 g/dL increase from baseline in average hemoglobin from Week 24 through Week 52, compared to 2.9% of placebo patients. In patients who achieved a hemoglobin response in the mitapivat arm, the mean change from baseline in average hemoglobin concentration from Week 24 through Week 52 was 1.6 g/dL.
Mitapivat also achieved statistical significance in two of three key secondary efficacy endpoints. The average change from baseline in hemoglobin concentration from Week 24 through Week 52 was 7.69 g/L, compared with 0.26 g/L in the placebo arm. Also, average change from baseline in indirect bilirubin from Week 24 through Week 52 was -16.03 µmol/L in the mitapivat arm and 0.88 µmol/L in the placebo arm.
“We plan to engage with the FDA to discuss these findings and our goal of bringing this innovative medicine to patients with sickle cell disease,” Sarah Gheuens, MD, PhD, Agios’ chief medical officer and head of R&D, said in a statement.
Gheuens added: “The RISE UP Phase [III] results further support mitapivat’s strong anti-hemolytic profile, as demonstrated in other rare blood disease trials. These effects can help address debilitating features of sickle cell disease that can profoundly worsen quality of life and lead to early mortality.”
Plunge, then bounce back
Investors appeared at first to differ with that upbeat assessment, taking a more bearish view as Agios shares plummeted 51% Wednesday from $45.49 to $22.34. But the stock bounced back 10% Thursday to $24.57, and finished last week rising another nearly 3% to $25.24 at Friday’s closing bell.
“We see a more challenging outlook for Agios as we head into 2026 given the uncertainties in the next steps for mitapivat in sickle cell disease (SCD) generated by the data from the [P]hase [III] RISE UP trial,” Tessa T. Romero, a senior analyst covering small- and mid-cap biotechnology companies with J.P. Morgan, wrote in a research note.
Romero and colleagues at J.P. Morgan now foresee a slower and more gradual launch for mitapivat in thalassemia should that be approved, based on RISE UP trial results, the dynamics and complexities of the thalassemia population, and the hepatocellular injury (HCI) signal that resulted in the FDA requesting of the company a Risk Evaluation and Mitigation Strategy (REMS) in thalassemia, even while acknowledging the unmet medical need for new thalassemia treatments.
Agios submitted a proposed REMS in September—a major amendment to its sNDA for mitapivat that resulted in a three-month extension of the FDA’s Prescription Drug User Fee Act (PDUFA) target decision date, to December 7.
As a result, J.P. Morgan lowered its 2026 worldwide revenue forecast for mitapivat in thalassemia, from $32.6 million to $28 million. But the firm has raised its forecasts for 2027 from $55.2 million to $74.3 million, and for 2028 from $95.2 million to $155 million.
Romero and colleagues chopped J.P. Morgan’s 12-month price target on Agios shares by 46%, from $37 to $20, after removing from her firm’s model the opportunity for mitapivat to generate sales in SCD. However, they maintained her firm’s “Neutral” rating on the stock.
By contrast, Luca Issi, PhD, senior biotechnology research analyst with RBC Capital Markets, downgraded his firm’s rating from “Outperform” to “Sector Perform” and slashed RBC’s price target 51%, from $57 to $28.
Joining RBC in cutting their price targets on Agio shares were:
BofA Securities (Alec Stranahan, PhD)—Down 41% from $54 to $32, maintaining “Buy” rating.
Goldman Sachs (Salveen Richter)—Down 37.5% from $40 to $25, maintaining “Neutral” rating.
C. Wainwright (Emily Bodnar)—Down 14% from $56 to $48, maintaining “Buy” rating.
Andrew Berens, MD, senior managing director, targeted oncology and a senior research analyst with Leerink Partners, also cut his firm’s price target on Agio 15% from $40 to $34—but upgraded the company’s shares from “Market Perform” to “Outperform,” based on the belief that Agios shares are significantly undervalued based on mitapivat’s piotential in thalassemia.
“We see the thalassemia PDUFA date (December 7, 2025) as a near-term catalyst not reflected at current AGIO levels that could confirm the value of the opportunity, which includes potential approval in a broader population than competitor luspatercept and a commercialization partnership in key geographies,” Berens wrote in a research note.
Luspatercept, now marketed as Reblozyl® (luspatercept-aamt) by Bristol Myers Squibb (NYSE: BMY) under license from Merck & Co. (NYSE: MRK), is an erythroid maturation agent whose indications include treating anemia in adult beta thalassemia patients. During Q1–Q3 2025, lustpatercept generated $1.661 billion in sales for BMS (up 35% from $1.226 billion a year ago) and $361 million in alliance revenue for Merck (up 38% from $261 million).
“We think [Agios] stock could rebound from current levels as investors consider the depressed valuation and optionality on the remaining pipeline and Pyrukynd expansion opportunities,” Berens wrote in a research note.
Leaders and laggards
Eli Lilly (NYSE: LLY) rose 2.2% from $1,043.29 to $1,066.65 at 1:51 p.m. Friday after the pharma giant became the first biopharma drug developer to achieve $1 trillion in market capitalization (the product of the share price and the number of outstanding shares). Lilly stock settled for a 1.63% gain after shares dipped later in the afternoon, finishing the day at $1,060.28 and a market cap of $950.495 billion. Lilly shares have soared since the company reported a 54% year-over-year revenue increase during the third quarter, driven by sales of its blockbuster glucagon-like peptide 1 (GLP-1) receptor agonist drug tirzepatide, marketed for type 2 diabetes as Mounjaro® and for obese or overweight adults as Zepbound®.
Olema Pharmaceuticals (NASDAQ: OLMA) share more than doubled, soaring 136% from $8.52 to $20.14 Tuesday after Roche (SIX Swiss: ROG) reported positive data for its oral selective estrogen receptor degrader (SERD) giredestrant in the Phase III lidERA trial (NCT04961996), which assessed the drug in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. Olema benefited from the news because its lead candidate, palazestrant (OP-1250), is also a SERD indicated to treat ER+/HER2- metastatic breast cancer. Palazestrant is under study in seven programs, two of them in Phase III—as a second- and third-line monotherapy (OPERA-01; NCT06016738), and as a first-line combination treatment with the CDK 4/6 inhibitor ribociclib, marketed by Novartis (SIX Swiss: NOVN) as Kisqali® (OPERA-02; NCT07085767). Roche shares rose 7% from CHF 287.20 ($355.55) to CHF 306.70 ($379.69) on the giredestrant news.
The post StockWatch: Avadel Sparks Bidding War; Agios Plummets 51% on Phase III Data appeared first on GEN – Genetic Engineering and Biotechnology News.
