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
Today, 4:44 PM
- In a regulatory filing, Clovis Oncology (NASDAQ:CLVS) reports that it has amended its 2011 license agreement with Pfizer (NYSE:PFE) that will allow Clovis to defer the payment of milestones due Pfizer upon the approval of an NDA in the U.S. and MAA in the EU for the first indication of rucaparib (PF-01367338). The change allows Clovis to defer such payment for 18 months in exchange for agreeing to pay a higher (undisclosed) amount.
- The NDA is currently under review in the U.S. The FDA's action date is February 23, 2017.
- Previously: FDA to review Clovis' rucaparib NDA for ovarian cancer, action date in six months; shares jump 31% (Aug. 23)
Tue, Aug. 23, 5:35 PM
Tue, Aug. 23, 3:52 PM
- Battered and bruised Clovis Oncology (CLVS +31%) recaptures some its former glory on the news that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations and who have been treated with least two chemo regimens.
- The NDA has Priority Review status which shortens the review clock to six months from the usual 10 months. The agency's action date (PDUFA) is February 23, 2017.
- In two late-stage studies, the overall objective response rate for rucaparib-treated ovarian cancer patients was 54% (n=57/106).
- Rucaparib is a small molecule poly ADP-ribose polymerase (PARP) inhibitor that specifically binds to PARP-1 and PARP-2. PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
- Clovis had lost ~90% of its value since late 2015 when it stumbled with rociletinib. Shares have rebounded of late. They are up more than 113% since bottoming at $11.57 on June 27.
- PARP inhibitor competitor TESARO (TSRO -5.9%) slumps on the news.
Mon, Aug. 8, 4:10 PM
Sun, Aug. 7, 5:35 PM
- AMPH, APLE, ARNA, ATSG, BKD, BLCM, BOJA, BWXT, CAI, CC, CLDX, CLNY, CLVS, CPE, CSC, CSLT, CUI, CVG, DTSI, DVA, EGN, EGY, ELNK, ENDP, ENV, FNV, HTZ, ICUI, IFF, IPHI, JPEP, KITE, LC, LXU, MAIN, MBI, MCHP, MODN, MTW, MXL, NCMI, NILE, NPTN, NUAN, NVGS, NVRO, NWSA, ONDK, OPK, OTTR, PFSW, PHH, PKY, PNM, PNNT, PRAA, PRI, RARE, RAX, RBA, RBC, REN, RMTI, ROG, RPD, RSPP, RWT, SHO, SINA, SREV, TUBE, TVIA, TWLO, VSLR, WB, WBMD, ZLTQ
Wed, Jun. 29, 12:46 PM
Wed, Jun. 29, 11:10 AM
Wed, Jun. 29, 9:24 AM
- Clovis Oncology (NASDAQ:CLVS) is up 17% premarket on robust volume in a ripple effect from the bullish action in TESARO (NASDAQ:TSRO) following its announcement of positive late-stage result for PARP inhibitor niraparib.
- Clovis' Phase 2-stage rucaparib is also a PARP inhibitor.
- PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
- Previously: TESARO's niraparib successful in late-stage ovarian cancer study clearing the way for regulatory submission in Q4; shares ahead 69% premarket (June 29)
Wed, Jun. 29, 9:16 AM
Fri, May 6, 12:20 PM
- Clovis Oncology (CLVS +1.8%) announces plans to cut staff 35% by the end of the year, prompted by the negative Ad Comm vote on rociletinib on April 12. It intends to maintain the size of its salesforce, though, in preparation for the potential U.S. launch of rucaparib in Q4 or Q1 2017.
- The company expects to receive a Complete Response Letter (CRL) from the FDA no later than June 28. The Oncologic Drugs Advisory Committee voted 12 - 1 against approval of rociletinib for the treatment of EGFR-positive non-small cell lung cancer citing the need for more late-stage efficacy data.
- Previously: FDA Ad Comm fails to back Clovis' rociletinib; shares down 12% (April 12)
Thu, May 5, 4:38 PM
Wed, May 4, 5:35 PM
- ABCO, ABTL, ACAD, ACET, AHS, AHT, AIRM, AL, ALEX, AMBR, AMH, ANET, APLE, ASYS, ATHX, ATVI, ATW, BBG, BCEI, BIO, BIOS, BLDR, BOJA, CAA, CARA, CERN, CINR, CLNE, CLVS, CMLS, CPA, CTRL, CYBR, CZR, DATA, DCT, DEPO, DIOD, DK, DKL, DV, DWA, EBS, ECOM, ED, EFC, EGAN, EGL, EGN, EGY, ELON, ENDP, ENV, EOG, ERII, ESL, EVC, EVDY, EVHC, FCE.A, FEYE, FISV, FLR, FPRX, FTD, GBDC, GEOS, GERN, GPRO, GSAT, GST, GUID, GXP, HLF, HTGC, ICPT, IMMR, IMPV, INAP, JCOM, LADR, LOCO, MAIN, MCHX, MDR, MDRX, MDVN, MELI, MHK, MITT, MNTX, MRIN, MSI, MTD, MTZ, NBIX, NGVC, NSTG, NWSA, OLED, OMED, OUT, OVAS, PACD, PCTY, PEGA, PETX, PKI, PMT, POST, PRSS, PTCT, PTLA, QLGC, RPTP, RRMS, RWT, SAAS, SEM, SEMG, SNCR, SPPI, SPWR, SPXC, SQ, SSNC, SWIR, TCRD, TEAM, TRMR, TRUE, TRQ, TRUP, TSRO, TWOU, UBNT, UEPS, UNXL, WAGE, WAIR, WEB, WIFI, WING, XNPT, Y, YELP
Fri, Apr. 15, 11:46 AM
- Celator Pharmaceuticals (CPXX +4.6%) initiated with Buy rating and $24 (63% upside) price target by Needham.
- Retrophin (RTRX -1.7%) initiated with Outperform rating and $25 (67%upside) price target by BMO Capital.
- Fate Therapeutics (FATE -3.2%) initiated with Outperform rating and $4 (85% upside) price target by BMO Capital.
- Tobira Therapeutics (TBRA +4.4%) initiated with Buy rating and $22 price target by H.C. Wainwright.
- Wright Medical Group (WMGI +2.4%) initiated with Buy rating and $23 (21% upside) price target by Bank of America.
- Cleveland Research rates UnitedHealth Group (UNH -0.9%) a Buy with a $155 (22% upside) price target; Anthem (ANTM -0.5%) a Buy with a $170 (20% upside) price target and Aetna (AET -0.4%) Neutral with a $120 (10% upside) price target.
- Glaukos (GKOS +0.3%) initiated with Hold rating by Stifel.
- Baxter International (BAX -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $58 (36% upside) from $39.
- Baird upgrades Exactech (EXAC +0.7%) to Outperform from Neutral and raises the price target to $26 (18% upside) from $21. Stryker (SYK -0.9%) downgraded to Neutral from Outperform and raises the price target to $116 (6% upside) from $111.
- Tenet Healthcare (THC -2.5%) upgraded to Positive from Neutral by Susquehanna.
- Clovis Oncology (CLVS -1.5%) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $15 (7% upside) from $42.
- AstraZeneca (AZN +0.3%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to 3,700p (11% downside risk) from 4,400p.
- Intercept Pharmaceuticals (ICPT +0.2%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $80 (48% downside risk) from $100.
Wed, Apr. 13, 12:47 PM
Tue, Apr. 12, 3:26 PM
- The FDA's Oncologic Drugs Advisory Committee votes 12-1 against accelerated approval of Clovis Oncology's (CLVS -11.8%) rociletinib for the treatment of EGFR-positive non-small lung cancer. The panel requires additional Phase 3 data to support its application.
- Results from TIGER-1 should be available in a couple of months. The FDA's action date (PDUFA) is June 28.
- If the FDA insists on data from the TIGER-3 study, results won't be available until 2019.
- Update: In a statement, Clovis confirms that the FDA wants to see the results from TIGER-3 before deciding on approval. Shares have resumed trading and are down on almost triple normal volume.
Tue, Apr. 12, 7:16 AM
- As usual with an Ad Comm review, trading in Clovis Oncology (NASDAQ:CLVS) is on hold pending the outcome of today's meeting of the FDA's Oncologic Drugs Advisory Committee during which it will discuss the company's New Drug Application (NDA) seeking approval of rociletinib for the treatment of EGFR-positive non-small cell lung cancer.
Clovis Oncology, Inc. is a biopharmaceutical company which focuses on acquiring, developing and commercializing cancer treatments in the United States, Europe and other international markets. The company has three product candidates in its clinical development pipeline: Rociletinib, Rucaparib... More
Country: United States