Today, 12:43 PM
Yesterday, 12:45 PM
Yesterday, 11:09 AM
- BioCryst Pharmaceuticals (BCRX -22.4%) heads south on almost triple normal volume in response to its update on the clinical development status of avoralstat (formerly BCX4161) for hereditary angioedema (HAE).
- Patient enrollment is complete in the Phase 2 OPuS-2 study, a 12-week, three-arm, parallel cohort trial designed to assess the safety and efficacy of avoralstat, 300 mg and 500 mg, administered three times per day compared to placebo. The primary efficacy endpoint is the average angioedema attack rate versus placebo. The estimated study completion date is early 2016.
- The company wants to defer a two-year carcinogenicity study in rats, something that is typically required at the time of the regulatory application. The European Medicines Agency (EMA) has agreed to defer it as a post-filing commitment, but the FDA has yet to make a decision. If it declines BioCryst's request then the NDA filing would be delayed until 2018 because the carcinogenicity study will not commence until early 2016. The company intends to address the issue during its End-of-Phase 2 meeting with the FDA early next year.
- HAE is a rare inherited condition characterized by excessive swelling in the extremities, face, genitalia and airway, which can be life-threatening. A peptide called bradykinin is the mediator of acute swelling attacks in HAE sufferers. Avoralstat inhibits plasma kallikrein, an enzyme that plays a key role in bradykinin production.
Tue, Sep. 1, 11:54 AM
- In a regulatory filing, BioCryst Pharmaceuticals (BCRX -1.3%) discloses that the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR/BARDA) has exercised its option under its agreement with the company to authorize $4.2M plus an additional $1.2M to fund various activities related to the continued development of BCX4430, a drug candidate for the potential treatment of more than 20 RNA viruses including Ebola and Marburg.
- The additional support increases the total value of the contract to $36.2M.
- Previously: BioCryst Pharma snags advanced development project for RNA pathogens (March 31)
Fri, Aug. 7, 7:40 AM
- BioCryst Pharmaceuticals (BCRX -4.1%) Q2 results: Revenues: $25.8M (+999%); R&D Expense: $16.5M (+48.6%); SG&A: $3.5M (+75.0%); Operating Income: $5.3M (+145.7%); Net Income: $4.9M (+133.6%); EPS: $0.06 (+126.1%); Quick Assets: $130.4M (+14.5%).
- 2015 Guidance: Net operating cash use: $18M - 28M; Operating expenses: $75M - 95M.
Fri, Aug. 7, 6:52 AM
Thu, Aug. 6, 5:30 PM
Thu, Jul. 2, 9:07 AM
- Onconova (NASDAQ:ONTX) upgraded to Overweight from Neutral with a $6 (131% upside) price target (up from $3) by Piper Jaffray.
- BioCryst Pharmaceuticals (NASDAQ:BCRX) upgraded to Buy from Neutral with a $19 (30% upside) price target (up from $12) by Bank of America.
- Kythera Biopharmaceuticals (NASDAQ:KYTH) downgraded to Market Perform from Outperform with a $65 (13% downside risk) price target (up from $61) by Leerink Swann.
- Zoetis (NYSE:ZTS) downgraded to Market Perform from Outperform with a $57 (18% upside) price target (up from $51) by BMO.
- China Cord Blood (NYSE:CO) downgraded to Neutral from Buy with a $6.75 (9% upside) price target (up from $6.50) by Roth Capital.
- Teladoc (Pending:TDOC) initiated with Outperform rating and $35 (23% upside) price target by RBC.
- Aldeyra (NASDAQ:ALDX) initiated with Buy rating and $16 (93% upside) price target by Canaccord Genuity.
- Novagen (NASDAQ:NVGN) initiated with Buy rating and $8.50 (89% upside) price target by H.C. Wainwright.
Fri, Jun. 19, 5:36 PM
Wed, Jun. 17, 10:08 AM
- BioCryst Pharmaceuticals (BCRX +1.8%) licenses Rapivab (peramivir injection), the world's only approved intravenous treatment for influenza, to Aussie biotech CSL Limited.
- CSL's subsidiary, bioCSL, will market the product globally with the exception of Japan, Korea, Taiwan and Israel. BioCryst also retains the right to pursue pandemic stockpiling orders for Rapivab from the U.S. government.
- Under the terms of the agreement, BioCryst will receive an upfront payment of $33.7M from bioCSL, up to $12M in milestones and tiered royalties on commercial sales. It will also be eligible to receive a percentage of the proceeds from government stockpiling purchases outside of the U.S.
- The FDA approved Rapivab, an intravenous viral neuraminidase inhibitor, in December 2014 for the treatment of acute uncomplicated influenza in adult patients who have been symptomatic for no more than two days.
Sun, May 10, 7:06 AM
- The World Health Organization has declared Liberia free of Ebola, marking the end of a national outbreak that infected as many as 400 new victims a week at its peak.
- Liberia has now gone 42 days - twice Ebola's maximum incubation period - since the burial of its last confirmed patient without discovering a new case.
- The disease is still spreading in Sierra Leone and Guinea, though at a slower pace. According to WHO statistics, more than 11,000 people have died from the virus, with about half of them in Liberia.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, LAKE, APT, VSR, SMED.
Fri, May 8, 9:19 AM
- BioCryst Pharmaceuticals (BCRX -0.2%) Q1 results: Revenues: $6.8M (+94.3%); R&D Expense: $17.1M (+85.9%); SG&A: $4.1M (+156.3%); Operating Loss: ($14.4M) (-94.6%); Net Loss: ($15.2M) (-50.5%); Loss Per Share: ($0.21) (-23.5%); Quick Assets: $108.6M (-4.7%).
- 2015 Guidance: Cash burn: $65M - 80M; Operating expenses: $75M - 95M.
Fri, May 8, 7:00 AM
Thu, May 7, 5:30 PM
Fri, May 1, 5:36 PM
Tue, Apr. 21, 9:42 AM
- Bristol-Myers Squibb (BMY +1.3%) upgraded to Overweight with $80 (21% upside) by Morgan Stanley.
- Align Technology (ALGN +4.6%) upgraded to Overweight with a $79 (46% upside) price target by Morgan Stanley.
- Biocryst Pharmaceuticals (BCRX +4.5%) upgraded to Neutral with $12 (20% upside) by Bank of America.
- Rosetta Genomics (ROSG -1%) upgraded to Buy with $5.50 (32% upside) price target by Cantor Fitzgerald.
- Phibro Animal Health (PAHC -2.7%) downgraded to Underweight with $35 (3% upside) price target by Morgan Stanley.
- Impax Laboratories (IPXL +0.5%) downgraded to Sell with $36 (28% downside risk) price target by UBS.
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