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
Competition Will Be Tough, But Clovis Oncology Has Legitimate Compounds
Stephen Simpson, CFA
Stephen Simpson, CFA
Today, 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)
Today, 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
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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.
Fri, Apr. 8, 5:40 PM
Fri, Apr. 8, 9:10 AM
- The FDA's Oncologic Drugs Advisory Committee will meet on Tuesday, April 12 to discuss Clovis Oncology's (NASDAQ:CLVS) New Drug Application (NDA) seeking approval of rociletinib for the treatment of patients with epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC).
- Based on the FDA's briefing document, a positive vote is far from certain. For example, the objective response rate (ORR), based on pooled data for the 500 mg, 625 mg and 750 mg dosage arms, was 30%, far short of AstraZeneca's (NYSE:AZN) Tagrisso (osimertinib) which showed a 59% ORR in clinical studies. Also, rociletinib's safety profile is concerning. In a pooled analysis, the most common adverse events were diarrhea (55%), nausea (52%), hyperglycemia (58%) and fatigue (44%). Serious adverse events (grade 3 or higher) were reported in 44% of patients receiving the 500 mg dose. 51% of patients (all dosages) had one or more dose reductions due to adverse events (40% of the 500 mg cohort). The incidence of adverse events in clinical studies for Tagrisso was no more than 25% for most (diarrhea: 42%, rash: 41%, dry skin: 31%).
- Investors appear unconcerned. Shares are up 2% premarket on robust volume.
- FDA briefing doc
- Errata to FDA briefing doc
- Company briefing doc
Mon, Apr. 4, 5:09 PM
- Clovis Oncology (NASDAQ:CLVS) had a rough day today as shares fell 11% on more than double normal volume. There appears to be a growing lack of confidence that the company's Breakthrough Therapy-tagged lung cancer candidate, rociletinib, will get a "thumbs up" at next week's Ad Comm meeting (Tuesday, April 12). The noise continues to build that the company has been less than forthright with the data from the Phase 3 study so there will be substantial scrutiny on the briefing docs that will be released no later (hopefully) than Friday, April 8.
- Shares plummeted last November when the company announced that the FDA requested additional efficacy data on both the 500 mg and 625 mg dosage groups. It also disclosed that the confirmed response rates were about 20 percentage points lower than expected (28% for 500 mg and 34% for 625 mg). So low, in fact, that its effectiveness appears to be well below rival AstraZeneca's (NYSE:AZN) Tagrisso (osimertinib), which showed an overall response rate of 59% in clinical studies. One industry expert, Kapil Dhingra, believes the company knew the confirmed response rates at the time of the ASCO presentations, two months before its NDA filing was completed, but failed to disclose the information to the market.
- The FDA's action date (PDUFA) is June 28. It was originally March 30 before the agency requested the additional data.
- Shares have lost ~85% of their value since mid-September.
- Now read Clovis Oncology Trying To Rebuild A Once-Bright Outlook
Sat, Apr. 2, 5:10 PM
Thu, Feb. 25, 4:09 PM
Wed, Feb. 24, 5:35 PM
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Wed, Jan. 27, 10:27 AM
- Clovis Oncology (CLVS -1.8%) commences a Phase 1b/2 clinical trial assessing the combination of Roche's (OTCQX:RHHBY +0.3%) atezolizumab (MPDL3280A) and rociletinib for the treatment of advanced EGFR-positive non-small cell lung cancer (NSCLC).
- The Phase 1b portion of the Clovis-sponsored study will evaluate the safety, tolerability and pharmacokinetics of the combination and the Phase 2 portion will assess the efficacy in two subgroups of EGFR+ NSCLC patients: those who have not previously received an EGFR tyrosine kinase inhibitor (TKI) or chemotherapy and those who have progressed on treatment with an EGFR TKI. T790M-negative and T790M-positive patients will be included in the Phase 1b and in the Phase 2 subgroup who have progressed on a prior EGFR TKI. Patients will not be required to be PD-L1-positive, although it will be assessed as part of the study.
- Rociletinib (CO-1686) is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR). It is currently under regulatory review in the U.S. and Europe.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor. It is under development for lung cancer, soft tissue sarcoma, breast cancer and colorectal cancer. Its rolling NDA submission in the U.S. for bladder cancer and lung cancer should be completed this quarter.
- Previously: FDA sets new PDUFA date for Clovis Oncology's rociletinib (Dec. 15, 2015)
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
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