Just months after hitting an all-time low, shares of Immune Design Corp. (NASDAQ:IMDZ) rocketed 310 percent higher Thursday to $5.82 as Merck & Co. Inc. moved to buy the immunotherapy developer for $5.85 cash per share, or about $300 million. The deal focuses on a portfolio of approaches to cancer immunization, adjuvant systems and technologies designed to enhance the ability of a vaccine to protect against infection, said Roger Perlmutter, president of Merck Research Laboratories.
Biomx Ltd., an Israeli microbiome company developing customized phage therapies, has closed a $32 million series B equity financing it said will be used primarily to advance its acne and inflammatory bowel disease (IBD) candidates to the clinic. BX-001, the acne program for which it has secured a global cosmetics-focused partner, is expected to enter a phase I trial in the second half of this year with an expected readout by year-end ahead of an additional trial in 2020. It will be followed by trials for the company's IBD program, BX-002, toward the end of 2020, Biomx CEO Jonathan Solomon told BioWorld.
Inventiva SA, of Daix, France, said a phase IIb trial evaluating the company's lead candidate, lanifibranor, for the treatment of diffuse cutaneous systemic sclerosis failed to meet its primary endpoint, sending company shares (PARIS:IVA) down 49.5 percent to close at €4.13 (US$4.68) on Tuesday. Investigators found no statistically significant difference between the placebo and lanifibranor-treated groups for the primary outcome of mean absolute change from baseline in a multipoint measure of skin thickness.
Not long after January's sharp rebound of the BioWorld Biopharmaceutical Index, a quartet of new companies is moving to join the public market, led by sizable offerings priced by mitochondrial dysfunction-focused Stealth Biotherapeutics Inc., which is raising $78 million, and corneal remodeling company Avedro Inc. with its $70 million offering. Alongside them, eczema specialist Hoth Therapeutics Inc. priced a small $7 million IPO and cancer drug developer Anchiano Therapeutics Ltd. closed a $30.5 million offering. Taken together with five other Nasdaq joiners, the moves raise February 2019's total IPO sum to $837.4 million, the most raised for a February since 2000, according to BioWorld data.
H. Lundbeck A/S and Otsuka Pharmaceutical Co. Ltd., co-developers of the atypical antipsychotic brexpiprazole, said that during two global phase III trials the medicine failed to prove statistically better than a placebo in reducing symptoms of mania for adults with bipolar I disorder. The companies, which already sell brexpiprazole as Rexulti for the adjunctive treatment of major depressive disorder and as a maintenance treatment for schizophrenia, said they will conduct an analysis of the study results to determine next steps.
The FDA's decision to accept a new drug application (NDA) for pitolisant, a medicine Harmony Biosciences LLC is advancing following the drug's 2016 EMA approval, throws open the door that 2019 could bring U.S. narcolepsy patients two new medicines for excessive daytime sleepiness (EDS). An FDA decision on Jazz Pharmaceuticals plc's solriamfetol filing, the other NDA in review, is expected by March 20. Both drugs will face competition from wake-promoting agents, such as modafinil and armodafinil, and generic stimulants.
Neurogene Inc., a New York-based company developing a pipeline of gene therapies for rare neurological diseases, has secured a $68.5 million series A financing to support its work. Investors in the adeno-associated virus (AAV)-focused startup included Samsara Biocapital, EcoR1 Capital, Cormorant Asset Management, Redmile Group and an undisclosed healthcare investment fund.
With a new drug application (NDA) filed at the FDA, SK Life Science Inc., part of one of South Korea's largest conglomerates, is taking a big step closer to gaining a foothold in the U.S. epilepsy treatment market. Now awaiting a Nov. 21 PDUFA date, the company's candidate cenobamate is poised to become its first-ever independent biopharma success in America. A commercial launch for the medicine, which would be initially marketed as an adjunctive therapy, could arrive as early as the first quarter of 2020. An approval would be followed by a 90-day DEA review for scheduling.
With a new drug application (NDA) filed at the FDA, SK Life Science Inc., part of one of South Korea's largest conglomerates, is taking a big step closer to gaining a foothold in the U.S. epilepsy treatment market. Now awaiting a Nov. 21 PDUFA date, the company's candidate cenobamate is poised to become its first-ever independent biopharma success in America.
NED Biosystems Inc., a Cambridge, Mass.-based venture developing a seven-agent combination therapy for cancer, has secured a U.S. patent for the treatment, called NED-170. The oral regimen, which comes in a daily seven-pill pack, targets both angiogenic and immune response pathways for the potential treatment of several types of cancers. If successful, it could potentially help not only extend lives, but also drive down the costs of cancer care in certain cases.
