Author Archive

ALXA reverse split. ALKS JNJ initiate Phase 3 schizophrenia. NYMX commences Phase 2 prostate cancer enrolment

Jun 13, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced a 1-for-10 reverse split of its common stock effective immediately. The number of common stock outstanding will correspondingly be reduced from approximately 119.6 million to approximately 12.0 million. Alkermes plc (NASDAQ: ALKS) announced that Janssen Research & Development, LLC has initiated a Phase 3 trial for a three-month formulation of INVEGA SUSTENNA(paliperidone palmitate), an injectable medicine […]

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Chatroom has been disabled

Jun 12, 2012 No Comments

I’ve decided to remove the chatroom from BioPharmCatalyst due to the high cost involved in maintaining the chatroom and a feeling that it doesn’t fit in with the philosophy of the website of giving unbiased tools for readers to use in their investing and trading decisions. I will continue to explore avenues to improve the website […]

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BIOD reverse split. ZIOP initiates Phase 3 SCLC trial. BPAX plans further LibiGel trials + AVNR PLX news

Jun 12, 2012 No Comments

Biodel Inc. (Nasdaq:BIOD) announced that it will effect a one-for-four reverse split prior to the start of trading on June 12, 2012. The number of authorized shares of common stock will be adjusted to 25m. ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that has initiated its Phase 3 MATISSE study (Multicenter Adaptive Trial Investigating Small cell lung cancer Survival Endpoints), of palifosfamide for the […]

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EXEL files shelf. CHTP cost-saving measures. ALNY initiates Phase 2 trial for ATTR.

Jun 08, 2012 No Comments

EXELIXIS INC (NASDAQ: EXEL) filed a mixed shelf today on a Form S‑3ASR to register an unspecified amount of equity or debt securities. The shelf becomes effective automatically without the requirement of review by the SEC. Companies classed as “well known seasoned issuers” (“WKSI”) may file an automatic shelf registration (ASR), which allows it to not specify the dollar […]

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FDA approves XNPT Horizant. OREX initiates cardio outcomes trial. AIS to transfer to NASDAQ. ACHN CMO resigns + NBY news

Jun 07, 2012 No Comments

GlaxoSmithKline plc (GSK) and XenoPort, Inc. (Nasdaq:XNPT) announced the FDA approved their supplemental new drug application of Horizant for the management of postherpetic neuralgia (PHN) in adults. Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that it has initiated its cardiovascular outcomes trial, called the Light-Study,  evaluating the occurrence of major adverse cardiovascular events (MACE) in patients taking Contrave, for the treatment of obesity. […]

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ARIA MRK receive CRL. VVUS Qnexa MAA decision delayed. ABT NBIX initiate Phase 3 endometriosis. DYAX analysis of ecallantide due within 3 months + SGYP

Jun 06, 2012 No Comments

Merck (NYSE: MRK) announced that the FDA issued a complete response letter (CRL) regarding the New Drug Application (NDA) for ridaforolimus for patients with metastatic soft tissue or bone sarcoma. The letter stated that additional clinical trial would need to be conducted to further assess safety and efficacy. ARIAD Pharmaceuticals, Inc (Nasdaq: ARIA) has a license […]

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BPAX reverse split. AVII proposes name change. MRNA winding down operations + ONTY news

Jun 01, 2012 No Comments

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced it will effect a 1-for-6 reverse split of its common stock on Monday, June 4, 2012. The reverse stock split will reduce the number of shares outstanding from approximately 120.8m to approximately 20.1m shares. The number of authorized shares will remain unchanged. The company had until July 30, 2012 to push […]

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CHTP and ALKS halt further trials following disappointing trial data + OMER news

May 31, 2012 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it failed to meet its primary endpoint in its Phase 2 trial of CH-4051 in patients with rheumatoid arthritis (RA). As a result it plans to discontinue development of CH-4051. Alkermes plc (NASDAQ: ALKS) said that it did not meet its “pre-specified criteria for advancing into Phase 3 clinical trials” […]

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ISIS PDUFA date set. LGND/GSK file Promacta sNDA. EXEL files NDA + initiates second Phase 3 mCRPC + CLSN ALNY INSM ACRX news

May 30, 2012 No Comments

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (ISIS), announced yesterday that the FDA has set a PDUFA date of of January 29, 2013 for  KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme. […]

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25 Upcoming Catalysts as of May 29, 2012

May 29, 2012 No Comments

25 short and long term potential catalysts as of May 29, 2012. See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take SHORT or LONG positions in certain stock. Alkermes plc (Nasdaq: ALKS) – Phase 2b data of ALKS […]

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Financial Database has been updated with 1Q 2012 cash positions

May 24, 2012 No Comments

The Financial Database has been updated with two key additions. 1) Cash, cash equivalents, and short term investments have been added as of the end of 1Q (March 31) 2012. Note that long term investments are not included in the figures. 2) Notes have been added where a company has raised cash through a direct […]

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