Catabasis Pharmaceuticals $CATB soared on Thursday amid increased volume trading in response to its announcement of joint research collaboration with Sarepta Therapeutics $SRPT to assess a combination drug approach for the treatment of Duchenne muscular dystrophy (DMD). Sarepta will contribute its know-how on exon skipping and Catabasis its expertise in [...]
Actinium Pharmaceuticals $ATNM announced its secondary offering of 8mn shares of common stock at $1.25. The underwriters will be eligible to purchase an additional 1.2mn shares. Shares, however, nosedived in reaction to the news. The net-proceeds from the offering are expected at $9mn and the closing date is October 4. [...]
South Korea�s Hanmi Pharmaceutical $HANPF signed an exclusive development and license agreement with Roche�s Genentech $RHHBY to develop and commercialize Hanmi�s pan-RAF inhibitor, Phase 1 clinical trial, HM95573. According to the terms of the agreement, Hanmi will receive an upfront fee of $80mn, $830mn in milestones, and tiered double-digit royalties [...]
As a part of its cost cutting measures, Novo Nordisk $NVO announced that it will slash 1000 positions from its international workforce of 42,300. Half of the job cuts will be in Denmark. The decision will be communicated through individual notices in the next two months. The cuts will effect [...]
Rennova Health, Inc. $RNVA inked a definitive agreement to acquire Pharmacogenetic Laboratory, Genomas. According to the terms of the deal, shareholders of Pharmacogenetic Laboratory will get $1.75mn in newly created series F convertible preference shares. $RNVA will assume about $800,000 of existing debt. Gualberto Ruano will continue to serve as [...]
Premarket Biotech Digest: $SRPT Doses First Patient in ESSENCE, $ATHX Gets SPA from FDA for Phase 3 Study, $AMGN Reports Positive Results
Sarepta Therapeutics $SRPT announced on Wednesday that the first patient received a dose in a Phase 3 clinical trial, ESSENCE, assessing SRP-4045 and SRP-4053 for the treatment of patients with Duchenne muscular dystrophy (DMD), amenable to exon 45 and exon 53 skipping. The double-blind, placebo-controlled clinical trial will [...]
Foamix Pharmaceuticals $FOMX priced its secondary offering of 6mn shares of common stock at $9.50. The offering includes 300K from standing shareholders. Underwriters will be eligible to purchase an additional 900K shares. The closing date is Sept. 30.
TRACON Pharmaceuticals $TCON entered in a strategic licensing collaboration with Janssen Pharmaceutica N.V. $JNJ for two of its unique oncology assets. The licensing agreement also includes a $5M equity investment in TRACON by Johnson & Johnson Innovation through the purchase of common stock at $5.95 per share.
ARIAD Pharmaceuticals $ARIA announced that its Japanese partner Otsuka Pharmaceutical $OTSKF, received marketing approval in Japan for Iclusig. The drug is intended for patients with intractable chronic myeloid leukemia and relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.
The late-stage pharmaceutical company, Novan $NOVN concluded its enrolment for two clinical trials that will assess its lead product candidate SB204, intended for patients with acne. The topline data is expected in the first of quarter of 2017.
Corbus Pharmaceuticals Holdings Inc. $CRBP is expected to show results from its phase 2 systemic sclerosis study on Wednesday.It is a clinical-stage pharmaceutical company, focused on the development and commercialization of therapeutics to treat rare or uncommon chronic and serious inflammatory and fibrotic diseases.
Athersys $ATHX announced on Wednesday that FDA agreed under a Special Protocol Assessment (SPA) for the design and planned evaluation of a Phase 3 clinical trial of MultiStem cell therapy product, intended to cure ischemic stroke. The outcome from the Phase 3 trial termed as, �MultiStem Administration for Stroke Treatment [...]
Anavex Life Sciences Corp. $AVXL inked a material transfer agreement with Biogen $BIIB under which Biogen will test Anavex�s lead drug candidate, ANAVEX 2-73 in an oligodendrocyte precursor cell (OPC) differentiation assay. A satisfactory outcome from the OPC assay study may lead to an in vivo remyelination study using a [...]
The first patient got enrolled for a Phase-3 clinical trial, VICTORIA, evaluating Bayer�s $BAYRY vericiguat for the treatment of patients with chronic heart failure with reduced ejection fraction. The trial is being led by collaborating partner, Merck $MRK.
Array BioPharma $ARRY increased the size of its public equity offering by 15% to $115mn or 18.4 million shares of common stock at $6.25. The underwriters will be eligible to buy an additional 2.76mn shares. The closing date is October 3. The proceeds from the secondary offering will be utilized [...]
Zogenix $ZGNX has two products, ZX008, low-dose fenfluramine for various types of epilepsies; and Relday, a long-acting SC risperidone injection for schizophrenia. ZX008 initiated phase 3 in January 2016 for Dravet’s syndrome, a rare type of epilepsy syndrome occurring very early in life. As people have discussed in our chatroom, [...]
AcelRx Pharmaceuticals $ACRX began a Phase 3 clinical trial, IAP312, evaluating Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe pain in adults in a hospital setting. The open-label study will enrol about 315 subjects who are hospitalized post-operations. They will self-administer sublingually (under the tongue) [...]
Amgen’s $AMGN Kyprolis regimen missed primary endpoints in late-stage study in certain multiple myeloma patients. A Phase 3 clinical trial, CLARION, assessing the combination of Amgen's KYPROLIS (carfilzomib), melphalan and prednisone (KMP) compared to Takeda's VELCADE (bortezomib), melphalan and prednisone (VMP) over 54 weeks in patients with newly diagnosed multiple myeloma who [...]
Idera $IDRA provided some valuable insights on its ongoing pre-clinical trial. It gave a new pre-clinical data on mechanism of action supporting selective targeting of single point mutations. The data indicates that 3GA could be used to treat diseases that require allele-specificity.
Bristol-Myers Squibb $BMY announced on Tuesday that it would assess the use of its blockbuster cancer immunotherapy Opdivo in combination with an experimental drug from Nektar Therapeutics to treat multiple cancers. Opdivo, which competes with Merck & Co's Keytruda, belongs to a costly new class of medicines branded PD-1 checkpoint [...]