Depression, Postpartum

Boston biotech Axonis Therapeutics has raised a $115 million Series A to test whether its oral drug AXN-027 can help patients with focal epilepsy and diabetic neuropathic pain. The financing, disclosed Wednesday morning, will get the biotech into the clinic around the end of this year, or about the same time Ovid Therapeutics expects to begin human trials with a similar approach by way of an AstraZeneca platform it licensed. Both companies are looking at KCC2, a CNS chloride transporter that is key to electrical signaling in the brain. KCC2 allows for neuronal GABA signaling. The GABA pathway has been targeted by multiple drugmakers , including Sage’s postpartum depression medicine Zurzuvae , but biotechs have yet to enter the clinic with a focus on KCC2, CEO Joanna Stanicka told Endpoints News . “Often GABA treatments can induce global inhibition, which leads to this cognitive impairment and sedation often reported by patients,” Stanicka said, adding that focused inhibition should avoid those side effects. The 13-employee biotech also said Wednesday that it added Donald Manning as chief medical officer and Jeff Imbaro as operating chief. Manning previously held the same post at Travecta, Pacira BioSciences and Adynxx. Imbaro was in the same role at stroke-focused Elevian, and before that he was a founding member of Vertex-acquired Semma Therapeutics. Axonis was founded by spinal cord injury patient advocate and board observer Bob Yant about 15 years ago, but it didn’t become “operational” until 2019, Stanicka said. Prior to the Series A, Axonis had raised about $34 million in seed funding and about $9 million in government and foundation money, Stanicka said. Its investors include Cormorant Asset Management, venBio, Sofinnova Investments, Merck’s corporate venture arm and others. The startup anticipates the Series A will fund AXN-027 through Phase 2 proof-of-concept studies, she said.

iStock, JHVEPhoto Biogen touted strong Q3 sales of its Alzheimer’s drug Leqembi a day after announcing a deal worth up to $1.45 billion with Neomorph to discover and develop molecular glue degraders. Biogen came out on top in the third quarter, exceeding revenue expectations overall and beating Wall Street expectations for Alzheimer’s drug Leqembi, which is slowly beginning to pick up steam after a slow start. The Cambridge, Mass.–based biotech reported $2.5 billion for the third quarter and raised its guidance for the year, expecting earnings per share (EPS) between $16.10 and $16.60, up from between $15.75 and $16.25, according to its report released Wednesday. In June and July 2024, Biogen hit $237 per share, but since then, its shares have been consistently falling. In premarket trading Wednesday morning, the company’s shares were down more than 1%, sitting at $180 per share. Sales of Biogen’s multiple sclerosis drugs were down across the board compared to Q3 2023, with Tecfidera falling to $232.8 million from $239.5 million and Tysabri down to $406.1 million from $456.3 million. On Biogen’s fourth-quarter 2023 earnings call, CEO Chris Viehbacher noted the company’s pivot away from its “legacy multiple sclerosis franchise” as one of five key primary objectives aimed at returning the company to growth. Biogen predicts total 2024 sales to decline by a low-single-digit percentage compared with last year but said it expects these decreases in multiple sclerosis product revenue to be offset by new product launches. One key product launch is that of Leqembi, which received full FDA approval in July 2023 but has struggled to gain traction in the market, in part due to delays in building intravenous infusion infrastructure, diagnostic test requirements and regular brain scans. However, sales have been increasing over the last few quarters, CNBC reported . The anti-amyloid antibody brought in $67 million in sales in the third quarter, exceeding Wall Street predictions of $50 million. Also on the neuro front, Biogen and partner Sage announced they will not pursue further development of recently approved postpartum depression (PPD) drug Zurzuvae in major depressive disorder (MDD). This news was revealed by Sage in its third-quarter earnings report on Tuesday. The companies won approval for Zurzuvae in August 2023 as the first pill for PPD but had hoped to capture a piece of the much broader MDD space. Meanwhile, Biogen became the latest biopharma company to ink a deal in the molecular glue space, tying up with Neomorph in a multi-target research collaboration. The deal, which will see Biogen lay down up to $1.45 billion, is aimed at discovering and developing molecular glue degrader clinical candidates in Alzheimer’s, rare neurological and immunological diseases. The partnership will marry Neomorph’s “leading molecular glue discovery platform” with Biogen’s “deep expertise” in these therapeutic spaces, according to a Tuesday press release . This is the second significant deal struck in molecular glues this week after Novartis announced Monday it would pay Monte Rosa Therapeutics $150 million upfront for the rights to that company’s VAV1-targeting molecular glue degraders. Under the agreement, Monte Rosa is eligible for up to $2.1 billion in development, regulatory and sales milestones.

Biogen and Sage Therapeutics are discontinuing further development of their drug Zurzuvae as a potential treatment for major depressive disorder, a move that follows last year’s FDA rejection of the therapy in that indication. The regulator had asked the companies to provide more evidence of efficacy from additional clinical testing. In its report of third quarter 2024 financial results posted Wednesday, Biogen said the discontinuation decision is based on the “significant new investment and time we expect would be needed to conduct additional studies.” Going forward, the two Cambridge, Massachusetts-based companies plan to focus their efforts on commercializing this drug in postpartum depression, for which it was approved last year. But postpartum depression is a much smaller market than major depressive disorder, which means Zurzuvae is unlikely to achieve the lofty sales once expected for the pill. With the renewed focus on Zurzuvae for postpartum depression, Sage will discontinue Zulresso, a product that in 2019 became the first FDA-approved postpartum depression drug. Zulresso is administered as a 60-hour infusion, a challenging dosing regimen that has limited market uptake of this Sage drug. By contrast, Zurzuvae is a pill taken once daily for 14 days. For the nine months ended Sept. 30, Sage reported Zulresso accounted for $3.1 million in revenue, down 63% compared to the same period in 2023. Sage said Zulresso will be commercially available until Dec. 31. Sponsored Post The Future of Hospitals and Pharma Companies Will Depend on Strength of Healthcare Analytics Insights PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies. By Stephanie Baum The collaboration between Biogen and Sage dates to 2020. Biogen committed $1.5 billion up front to begin the R&D alliance focused on depression and movement disorders. Results have been disappointing. Besides Zurzuvae’s rejection in major depressive disorder, collaboration on the movement disorders program SAGE-324 is ending. In July, the companies reported this oral drug failed a Phase 2 test in essential tremor. Biogen gave Sage a termination notice for SAGE-324 last month. When the termination becomes effective in February, Sage will become fully responsible for the program. In its quarterly report, Sage said it plans to evaluate other potential indications for this drug. In a note sent to investors, Leerink Partners analyst Marc Goodman said the discontinuation of further development of Zurzuvae in major depressive disorder was expected. While Leerink projects the drug could achieve $200 million to $300 million in peak sales in postpartum depression, physicians have told the firm they’re skeptical of a paradigm shift in treatment and the black box warning on the product’s label could further limit use. Sage does have other programs in the pipeline, but the company will have fewer workers to support them. In its quarterly report, the company said it will commence a business restructuring to strengthen its balance sheet and focus on the ongoing launch of Zurzuvae for postpartum depression. Sage said it will shed about 33% of its workforce. With the restructuring, the company said it expects to have enough capital to support operations into 2026.