After a previous phase III failure, Savara Inc. kept at it and found success with molgramostim for the rare lung disease autoimmune pulmonary alveolar proteinosis. A second attempt, the pivotal phase III Impala-2 study of molgramostim, an inhaled form of recombinant granulocyte macrophage colony-stimulating factor for adults, hit its primary endpoint and left participants breathing easier. The first phase III study with molgramostim, comprising 138 patients and labeled Impala, missed its primary endpoint in June 2019 but showed a statistically significant improvement in a key secondary endpoint, prompting Savara to try again. The company’s futures spiked at $5.59 per share (NASDAQ:SVRA) before the opening bell on June 26 but had settled to $3.47 each at midday, an 8.5% drop. APAP affects an estimated seven to 26 people per 1 million population, or roughly 2,000 to 8,000 people in the U.S. Lavage treatment has been the only way to extend their lives.

Lyell sinks on phase I death, despite ROR1 CAR T efficacy

A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial. The patient who died experienced grade 5 respiratory failure at day 41, although it is not clear as to whether the death was treatment related. “I think the most important thing about ‘797 is we are seeing this dose-dependent clinical activity and we have validated our anti-exhaustion technology, so number one, we know that we have an active drug, but we need to, of course, determine the appropriate dose and how to manage the pneumonitis,” Lynn Seely, Lyell’s president and CEO, said in a morning investor call. Lyell’s shares (NASDAQ:LYEL) fell by 35% to $1.33 in early trading June 26.

Radiopharm raises AU$70M as it brings on new investor Lantheus

Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million. Subject to shareholder approval, Lantheus has the option to invest a further AU$7.5 million within six months. In addition to the equity investment, Lantheus will sublicense two of Radiopharm’s preclinical assets for AU$3 million up front. Assets covered under the agreement include a TROP2-targeting nanobody and a LRRC15-targeting monoclonal antibody.

Fed Circuit resuscitates skinny label infringement challenge

In reviving another case involving label carveouts, the U.S. Court of Appeals for the Federal Circuit yesterday insisted that its decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not eviscerate the so-called skinny labels that allow generics to come to market even though some of the brand’s indications still have patent protection. Determining that Amarin failed to state a claim, a federal district court had tossed the company’s induced infringement claims against Hikma that involved patents protecting a cardiovascular indication for Amarin’s blockbuster drug, Vascepa (icosapent ethyl). The Federal Circuit disagreed, returning the case to the lower court for full consideration of the facts.

GC Cells shares drop as MSD terminates $1.8B deal with Artiva

Merck Sharp & Dohme Corp. (MSD), known as Merck & Co. Inc. in the U.S. and Canada, terminated its potential $1.86 billion deal with San Diego-based Artiva Biotherapeutics Inc. for novel chimeric antigen receptor-natural killer (NK) cell therapies. Shares of South Korea’s GC Cell Corp. (KOSDAQ:144510), Artiva’s largest stakeholder along with Green Cross Holdings, dropped 7.77% on the Korean stock exchange on the news in intraday trading, closing at ₩28,700 (US$20.64) June 26. Green Cross Holdings shares (KOSPI:005250) were also down 1.69% June 26 from the day prior, closing at ₩14,000.

Also in the news

Abbvie, Alligator, Arialys, Ascendis, Astrazeneca, Augustine, Benevolentai, Beyond Air, Bioxcel, Botanix, Capricor, Carisma, CDR-Life, Compass Pathways, Corcept, Curie.Bio, Dermavant, Douglas, Ethris, Excellthera, Formation, Harmony, Innovent, Intellia, Ionis, Janssen, Junshi, Lipocine, Lundbeck, MBX, Medicure, Merck, Novo Nordisk, Nervgen, Oruka, Otsuka, Rigel, Roche, Solarea, Soligenix, Tevogen, Wave, Werewolf, Zealand