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Wednesday, December 4, 2019

Invitae down 5% on bearish Hedgeye call

Genetic testing services provider Invitae (NVTA -4.8%) slips on below-average volume in apparent response to a new (but not yet posted) report from independent research shop Hedgeye that sees a 30 – 50% downside in shares.
The stock is currently exchanging hands at $18.14, down 37% from the all-time high of $28.75 on August 7.
Q3 revenue was up 51% to $56.5M, $1.7M above consensus.
Q4 views expect a loss/share of ($0.67) on revenue of $69.2M.
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Allakos soars on sale chatter

Following a volatility halt, Allakos (NASDAQ:ALLK) is now up 38% on chatter about a possible sale.
Update: Bloomberg reports that informed sources have confirmed that the company is exploring strategic alternatives and has engaged a financial advisor to assist. Shares are up 42% nearing the close on an 8x surge in volume.
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Progyny EPS beats by $0.01, beats on revenue

Progyny (NASDAQ:PGNY): Q3 Non-GAAP EPS of $0.03 beats by $0.01; GAAP EPS of -$1.10 misses by $1.11.
Revenue of $61.2M (+120.1% Y/Y) beats by $0.37M.
Shares +0.27%.
Press Release
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Aurinia’s voclosporin successful in late-stage lupus nephritis study

A 357-subject Phase 3 clinical trial evaluating Aurinia Pharmaceuticals’ (NASDAQ:AUPH) lead drug voclosporin, combined with mycophenolate and low-dose corticosteroids, in lupus nephritis patients met the primary and key secondary endpoints.
Specifically, 48% of treated participants achieved renal response at week 52 (the primary endpoint) compared to 22.5% for placebo (p<0.001).
Statistically significant results were also observed in the proportion of renal responders at week 24 (32.4% vs. 19.7%), partial responders at weeks 24 and 52 and time to achieve a urinary protein-to-creatinine ratio (UCPR) of 0.5 or less.
No new safety signals were observed.
Additional data will be submitted for presentation at a future medical conference.
The company plans to file a U.S. marketing application in H1 2020 under Fast Track status.
Management will host a conference call tomorrow, December 5, at 8:30 am ET to discuss the results.
Shares, currently halted, will resume trading at 4:35 pm ET.
Update: Shares up 115% after hours.
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FDA OKs Roche’s Tecentriq for first-line lung cancer

The FDA approves Roche (OTCQX:RHHBY) unit Genentech’s Tecentriq (atezolizumab), combined with chemo [Celgene’s Abraxane (paclitaxel protein-bound; nab-paclitaxel) and carboplatin], for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK mutations.
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Dr. Reddy’s launches bortezomib for injection in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) has launched Bortezomib for Injection 3.5 mg/vial, approved by the FDA for intravenous use only. It is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
The branded version is Takeda Pharmaceutical’s (NYSE:TAK) Velcade, administered IV and subcutaneously.
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CASI Pharma’s CD19 CAR-T clinical trial applications OK’d in China

The China National Medical Product Administration (NMPA) has approved CASI Pharmaceuticals’ (NASDAQ:CASI) clinical trial applications for CNCT19 (CD19 CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL) submitted by its partner Juventas Cell Therapy Ltd.
The Company expects to start enrolling patients in early 2020.
CASI has previously acquired exclusive worldwide commercial rights to CNCT19 from Juventas.
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