On the morning of Aug. 7, while Sage Therapeutics Inc. executives discussed the U.S. FDA’s approval of Zurzuvae (zuranolone) for treating postpartum depression (PPD) and its concurrent complete response letter (CRL) for treating major depressive disorder (MDD), the company’s stock sank dramatically. By midday, shares (NASDAQ:SAGE) were trading 52% downward at $17.35 each. The agency approved Zurzuvae as the first oral medication for treating PPD in adults but issued the CRL for MDD, cutting a much larger potential patient market out from beneath Sage and its collaborator, Biogen Inc. Sage said it disagrees with the agency’s decision and will launch the PPD therapy before year’s end as it reevaluates its pipeline and reorganizes its workforce.

Vistagen skyrockets on phase III fasedienol success in social anxiety disorder

South San Francisco-based Vistagen Therapeutics Inc.’s stock (NASDAQ:VTGN) soared 850% midday on Aug. 7 following the release of top-line phase III results of fasedienol (PH-94B) for social anxiety disorder. In the Palisade-2 trial, the nasal spray showed a statistically significant rapid-onset reduction in patient-reported Subjective Units of Distress Scale score compared to placebo in a public speaking challenge. It also hit a secondary endpoint, demonstrating a statistically significant reduction in proportion of responders compared to placebo as measured by the Clinical Global Impressions Improvement scale. Fasedienol was well-tolerated and exhibited no severe or serious adverse events.

Nektar gets much-needed boost on corrected data for rezpeg; phase IIb AD trial next

Nektar Therapeutics Inc. has found itself on much more solid footing for its planned phase IIb trial of rezpegaldesleukin in atopic dermatitis. After regaining full rights to the drug from former partner Eli Lilly and Co., Nektar discovered erroneous calculations had been made when reporting earlier phase Ib study results, which, when corrected, demonstrated clear statistical significance for the Treg stimulator vs. placebo. Shares of Nektar (NASDAQ:NKTR), which have tumbled over the past year on disappointing data and company cutbacks, were enjoying a 56% boost at midday.

Astellas-bought Iveric gains FDA clearance for eye drug Izervay

Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy (GA) – snagging FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023. Cranbury, N.J.-based Iveric’s approval comes on the heels of approval for Apellis Pharmaceutical Inc.’s GA drug Syfovre (pegcetacoplan) – the first to gain clearance in February 2023.

One in, one out: Bavarian Nordic prepares chikungunya filing as RSV vaccine falls by wayside

The dent made in Bavarian Nordic A/S’ future revenues after it dropped development of late-stage respiratory syncytial virus (RSV) contender MVA-BN-RSV could be offset by potential sales of its chikungunya virus (CHIKV) vaccine, PXVX-0317, if recent phase III immunogenicity data manage to persuade the U.S. FDA that it’s as worthy as Valneva SA’s VLA-1553, the other chikungunya vaccine racing to be first to market. Although preparations are underway to file for approval for PXVX-0317 in both the U.S. and Europe next year with hopes of a 2025 launch date, Copenhagen, Denmark-based Bavarian Nordic said in a conference call that it expects Valneva’s prospect to become available “at least a year before” PXVX-0317 arrives on the scene, which, although not ideal, does at least enable it to “piggyback” onto the extensive marketing it predicts Valneva will soon undertake.

US IRS pushes forward with Rx negotiation tax penalty

Even as biopharma challenges to the constitutionality of the “excise tax” included in the Inflation Reduction Act (IRA) await action in the U.S. federal court system, the Treasury Department and the Internal Revenue Service announced Aug. 4 that they intend to issue proposed regulations to implement the tax when the negotiated prices go into effect in 2026. The IRA established the escalating tax to deter drugmakers from undermining the forced Medicare negotiations. But various court challenges to the negotiation process claim the tax violates the Eighth Amendment Excessive Fines Clause.

US Senate eyes two new legislative proposals for False Claims Act litigation

U.S. federal government agency recoveries under the False Claims Act are down slightly in the first half of 2023 relative to the first half of 2022, but that doesn’t mean companies in the life sciences can afford to let their guard down. The Senate is examining two pieces of legislation that would significantly amplify the risk for device and drug makers, including a Senate bill that would eviscerate the materiality standard as set by the U.S. Supreme Court in Escobar.

Also in the news

Aceragen, Adamis, Amgen, Ankyra, Arbor, Arcus, Avalyn, Basilea, Biontech, Collegium, Cybin, Dualitybio, Eli Lilly, Gracell, Ikena, IO Biotech, Mesoblast, Neurobo, Oncopeptides, Oragenics, Pionyr, Poseida, Sanofi, Serimmune, Taiho, Theracosbio, Viracta, Vivoryon, Voyager, Xortx