Clovis Oncology Trying To Rebuild A Once-Bright Outlook
Stephen Simpson, CFA
Stephen Simpson, CFA
Clovis Oncology: Derisked Takeout Story
Poonam A. Arora • 19 Comments
Poonam A. Arora • 19 Comments
Thu, Nov. 3, 4:08 PM
Wed, Nov. 2, 5:35 PM
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Fri, Oct. 28, 12:40 PM
- Cidara Therapeutics (NASDAQ:CDTX) initiated with Buy rating by Cantor Fitzgerald.
- Ohr Pharmaceuticals (NASDAQ:OHRP) initiated with Buy rating and $10 (223% upside) price target by H.C. Wainwright.
- Sarepta Therapeutics (NASDAQ:SRPT) initiated with Equal Weight rating and $53 (28% upside) price target by Morgan Stanley.
- AMAG Pharmaceuticals (NASDAQ:AMAG) initiated with Buy rating and $40 (58% upside) price target by Needham.
- Nabriva Therapeutics (NASDAQ:NBRV) initiated with Outperform rating and $14 (138% upside) price target by Leerink Swann.
- Paratek Pharmaceuticals (NASDAQ:PRTK) initiated with Outperform rating and $23 (107% upside) price target by Leerink Swann.
- Glaukos (NYSE:GKOS) initiated with Outperform rating and $42 (midpoint) (26% upside) price target by Wells Fargo.
- Calithera Biosciences (NASDAQ:CALA) initiated with Sell rating and $1 (62% downside risk) price target by Citigroup.
- Heron Therapeutics (NASDAQ:HRTX) initiated with Buy rating and $41 (173% upside) price target by Aegis Capital.
- Clovis Oncology (NASDAQ:CLVS) initiated with Sell rating and $15 (50% downside risk) price target by Chardan Capital.
- Fulgent Genetics (Pending:FLGT) initiated with Overweight rating and $13 (42% upside) price target by Piper Jaffray. Initiated with Buy rating and $15 (64% upside) price target by BTIG Research.
- Tabula Rosa Healthcare (Pending:TRHC) initiated with Outperform rating and $17 (38% upside) price target by Wells Fargo.
- Xenon Pharmaceuticals (NASDAQ:XENE) initiated with Buy rating and $18 (121% upside) price target by Stifel Nicolaus.
Tue, Oct. 25, 9:16 AM
Fri, Oct. 7, 12:47 PM
Fri, Oct. 7, 11:04 AM
Fri, Oct. 7, 9:22 AM
- Clovis Oncology (NASDAQ:CLVS) is down 20% premarket on robust volume in response to its announcement of mid-stage trial data on PARP inhibitor rucaparib in certain patients with treatment-resistant advanced ovarian cancer, an indication that is currently under FDA review (action date is February 23, 2017). The results are being presented at the European Society for Medical Oncology 2016 Congress in Copenhagen.
- Data from subgroups from two Phase studies, ARIEL2 and Study 10, were combined for an integrated efficacy and safety analysis. 377 patients met the criteria for inclusion to assess safety and 106 for efficacy. The recommended oral dose of rucaparib was 600 mg.
- In the efficacy population, most (61%) had received at least three prior lines of therapy while 39% received two prior lines. The objective response rate (ORR) was 54% (n=57/106), including nine (9%) complete responders, 48 (45%) partial responders and 36 (34%) with stable disease. Four were not evaluable. Median duration of response by investigator assessment was 9.2 months.
- All 377 (100%) patients assessed for safety experienced a treatment-related adverse event (TRAE), including 229 (61%) with a grade 3 (severe) or higher adverse event. TRAEs leading to dose interruption occurred in 221 (59%) of patients and in 167 (44%) leading to dose reduction. Nine patients died, eight due to cancer progression and one due to sepsis, which the investigator determined to be unrelated to treatment.
- The company's fortunes are riding on rucaparib after striking out with rociletinib.
Fri, Oct. 7, 9:14 AM
Fri, Sep. 23, 8:28 AM
- Clovis Oncology (NASDAQ:CLVS) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $41 (7% upside) from $19.
- Sarepta Therapeutics (NASDAQ:SRPT) upgraded to Outperform from Market Perform with a $64 (5% upside) price target by Cowen and Company. Upgraded to Hold from Underperform with a $50 (18% downside risk) price target by Jefferies. Upgraded to Outperform from Market Perform with an $88 (44% upside) price target by William Blair. Upgraded to Neutral from Reduce by SunTrust Banks. Price target raised to $48 (21% downside risk) from $4. Upgraded to Market Perform from Underperform with a $50 (18% downside risk) price target by Leerink Swann. Upgraded to Buy from Neutral by Janney Montgomery Scott. Price target raised to $65 (7% upside) from $30.
- Molina Healthcare (NYSE:MOH) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $58 (2% downside risk) from $51.
- Tobira Therapeutics (NASDAQ:TBRA) downgraded to Hold from Buy by Cantor Fitzgerald. Price target raised to $42 (6% upside) from $19.
- OraSure Technologies (NASDAQ:OSUR) downgraded to Neutral from Buy by BTIG Research. $8 price target removed.
Thu, Sep. 22, 10:45 AM
- Buoyed in large part by the FDA's approval of Sarepta Therapeutics' (SRPT +4.4%) Exondys 51 for Duchenne muscular dystrophy and Allergan's (AGN +1.9%) over-the-top acquisition of NASH player Tobira Therapeutics (TBRA +0.6%), money flow has turned decidedly bullish for biotechs. On a technical basis, the iShares Nasdaq Biotechnology ETF (IBB +0.6%) is poised for a breakout through 300, a healthy 25% turnaround from the low of ~240 in June.
- There is a laundry list of leaders in the rally, including bluebird bio (BLUE -0.1%), Clovis Oncology (CLVS +5.4%), Puma Biotechnololgy (PBYI +3.8%), Aerie Pharmaceuticals (AERI -2.1%) and CoLucid Pharmaceuticals (CLCD -3.7%).
Wed, Sep. 21, 9:17 AM
Tue, Sep. 20, 5:37 PM
Tue, Sep. 20, 4:59 PM
- Clovis (NASDAQ:CLVS) has always been considered an acquisition target with a “long list” of potential suitors including Eli Lilly (NYSE:LLY), Merck & Co. (NYSE:MRK) , and Roche, Janney tells Bloomberg in an interview.
- CEO Patrick Mahaffy has sold other companies including Pharmion, NeXstar Pharmaceuticals.
- Clovis closed +12.7% and is up another 7.7% AH. Earlier today the stock jumped when Gilead (NASDAQ:GILD) said it is looking for cancer deals.
- Clovis's PDUFA date for ovarian cancer drug rucaparib is Feb. 23, 2017.
Thu, Sep. 8, 12:50 PM
Thu, Sep. 8, 11:00 AM
Thu, Sep. 8, 9:44 AM
- Clovis Oncology (CLVS +10.9%) perks up on increased volume in response to its announcement that the FDA has informed it that it has no plans to hold an Advisory Committee meeting to discuss the company's New Drug Application (NDA) seeking accelerated approval of rucaparib for the treatment of ovarian cancer, normally a bullish development. The FDA's action date (PDUFA) is February 23, 2017.
- The market has been discounting the positive news for some time now. Shares are up 132% since bottoming at $11.57 on June 27.
- Previously: FDA to review Clovis' rucaparib NDA for ovarian cancer, action date in six months; shares jump 31% (Aug. 23)