ACHV Soared As Much As 145%. What Awaits SRPT, HTBX, KPTI This Week?

(RTTNews) - Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost their stock price while unfavorable results can send the stocks plummeting.

Achieve Life Sciences Inc. (ACHV) rose as much as 145% to $4.54 in intraday trading on February 22, before settling down at $3.30, up 82.32%, at the close of the trading, thanks to encouraging phase I/II multi-dose, pharmacokinetic and pharmacodynamics data of Cytisinicline in smokers.

Zosano Pharma Corporation (ZSAN) jumped more than 170% on February 21, to close the day's trading at $6.00, following favorable results from its long-term safety study for Qtrypta, in which patients treated migraine attacks over a one year period.

Just like clinical trial results, regulatory events like FDA panel recommendations and FDA decision can also make or break the pharma/biotech stocks.

Karyopharm Therapeutics Inc. (KPTI) cratered over 40% on February 22, as FDA staff concluded that there is only limited efficacy and significant toxicity in relapsed refractory multiple myeloma patients treated with Selinexor. An FDA panel is slated to review Selinexor on February 26.

Let's look at some of the upcoming week's clinical trial and regulatory catalysts.

1. Bausch Health Companies Inc. (BHC)

The FDA decision on Bausch Health's New Drug Application for its sub-micron Loteprednol etabonate ophthalmic gel, 0.38% is expected on February 25.

This product, which has a reduced concentration and reduced dosing frequency compared to existing formulations of Loteprednol etabonate, is proposed for the treatment of post-operative inflammation and pain following ocular surgery.

The Company's Loteprednol etabonate ophthalmic suspension 0.5% is approved under brand name Lotemax and is used to treat swelling and redness caused by certain eye conditions or surgery.

BHC has traded in a range of $17.20 to $28.45 in the last 1 year. The stock closed Friday's trading at $23.75, up 1.02%.

2. Karyopharm Therapeutics Inc. (KPTI)

An FDA panel is scheduled to review Karyopharm Therapeutics Inc.'s (KPTI) multiple myeloma drug candidate Selinexor on February 26.

The Company is seeking approval of Selinexor as a new treatment for patients with penta-refractory multiple myeloma.

The briefing documents posted by the FDA staff ahead of the panel meeting don't look good. It reads as "Given the limited efficacy and significant toxicity demonstrated in this population, it is unclear whether treatment with selinexor-dexamethasone provides a clinically meaningful benefit that outweighs the risks of treatment".

The briefing documents are used as the basis for discussion by the FDA panel members. The FDA decision on Selinexor is expected on April 6, 2019.

KPTI has traded in a range of $4.65 to $21.71 in the last 1 year. The stock closed Friday's trading at $ $5.07, down 43.48%.

3. Sarepta Therapeutics Inc. (SRPT)

Sarepta is a commercial-stage biopharmaceutical company focused on developing precision genetic medicine to treat rare neuromuscular diseases, primarily Duchenne muscular dystrophy.

The Company's drug EXONDYS was granted accelerated approval in the U.S. for Duchenne muscular dystrophy in September 2016, despite an FDA panel recommending against its approval. The approval of EXONDYS is considered one of the controversial decisions.

The Company has a number of investigational gene therapies in its pipeline - one of which is MYO-101 to treat patients with Limb-Girdle Muscular Dystrophy Type 2E (beta-sarcoglycanopathy).

Watch out for...

Results from the first 3-patient cohort of phase I/IIa gene transfer clinical trial of MYO-101 to treat patients with Limb-Girdle Muscular Dystrophy Type 2E (beta-sarcoglycanopathy) are expected to be announced on February 27.

SRPT has traded in a range of $59.51 to $176.50 in the last 1 year. The stock closed Friday's trading at $139.98, up 2.52%.

4. Heat Biologics Inc. (HTBX)

Heat Biologics is a biopharmaceutical company developing immunotherapies against cancer.

The Company's lead drug candidate is HS-110, which is being evaluated in combination with Bristol-Myers Squibb Co.'s (BMY) Opdivo, for the treatment of advanced non-small cell lung cancer in a phase II trial.

Watch out for...

New interim data from the phase II study of HS-110 in advanced non-small cell lung cancer is scheduled to be presented at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on February 28.

HTBX has traded in a range of $0.95 to $4.30 in the last 1 year. The stock closed Friday's trading at $1.37, up 0.74%.