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IMGN Prices Upsized Offering, STRM Rises On Q1 Results, PTI Tanks After-Hours

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Today's Daily Dose brings you news about ImmunoGen's stock offering; Ascendis securing Orphan Drug Designation for TransCon PTH; Streamline Health's strong quarterly results; FDA granting Rare Pediatric Disease Designation for Cellectar's CLR 131, and Proteostasis' phase I study results of PTI-801 in cystic fibrosis patients.

Read on…

Ascendis Pharma A/S' (ASND) TransCon PTH, a long-acting prodrug of parathyroid hormone (PTH) in development for hypoparathyroidism, has been granted Orphan Drug Designation by the FDA.

The Company plans to initiate a phase III program for TransCon PTH in the first quarter of 2019, pending discussions with regulatory agencies.

ASND closed Wednesday's trading at $70.00, down 1.09%.

Cellectar Biosciences' (CLRB) lead Phospholipid Drug Conjugate product candidate, CLR 131, has been granted Rare Pediatric Disease Designation by the FDA for the treatment of rhabdomyosarcoma, a rare pediatric cancer.

Rare Pediatric Disease Designation is given to diseases that primarily affect children from birth to 18 years old, and affect fewer than 200,000 persons in the U.S.

CLR 131 is currently being evaluated in multiple Phase 2 and Phase 1 clinical studies.

CLRB closed Wednesday's trading at $1.02, up 10.88%.

ImmunoGen Inc. (IMGN) priced an upsized underwritten public offering of 13.7 million shares of its common stock at a price of $11.00 per share. The previously announced offering size was 12 million shares of common stock.

The underwriters have been granted a 30-day option to purchase up to an additional 2.05 million shares of common stock at the public offering price, less the underwriting discount.

The Company's lead product candidate is Mirvetuximab soravtansine, an ADC, under a phase III trial as a single agent for the treatment of platinum-resistant ovarian cancer, dubbed FORWARD I, and under a phase 1b/2 study as combination regimens for both platinum-resistant and platinum-sensitive ovarian cancer, known as FORWARD II.
In the FORWARD II trial, Mirvetuximab soravtansine is evaluated in combination with Avastin, carboplatin, Doxil or Keytruda.

Last month, the Company announced positive data from the FORWARD II trial evaluating mirvetuximab soravtansine in combination cohorts of Avastin and carboplatin in patients with folate receptor alpha (FRa)-positive ovarian cancer.

The Company is enrolling an additional 35 patients with medium or high FRa expression levels in an expansion cohort in the FORWARD II study, and expects to present data from this cohort later this year.

IMGN closed Wednesday's trading at $11.39, down 0.70%. In after-hours, the stock was down 1.67% to $11.20.

Proteostasis Therapeutics Inc. (PTI) announced results from its ongoing 14-day phase I dosing study of PTI-801 in cystic fibrosis patients on background Orkambi therapy.
According to the trial results, at higher doses, PTI-801 demonstrated a statistically significant improvement in Sweat chloride (SC) and body mass index (BMI) in the 14-day treatment period.

Change in ppFEV1 was evaluated as part of the safety analysis. An improvement in ppFEV1 was observed across all dose cohorts, but the change was not statistically significant.

In hyperglycemic cystic fibrosis-related diabetes subjects, PTI-801 led to a statistically significant normalization of glucose levels at the three dose levels analyzed, the Company added.

A phase I study of a double combination of PTI-801 and PTI-808 in cystic fibrosis is ongoing, and initial results are expected later this year.

A phase II study of a triple combination of PTI-428 + PTI-801 + PTI-808 is expected to be initiated by the end of this quarter - with results expected later this year.

PTI closed Wednesday's trading at $4.90, up 1.45%. In after-hours, the stock was down 14% to $4.21.

Streamline Health Solutions Inc. (STRM) has reported strong financial results for the first quarter ended April 30, 2018.

Net loss for the recent first quarter narrowed to $568,699 or $0.03 per share from $2.04 million or $0.10 per share in the year-ago quarter. Revenues for the three-month period ended April 30, 2018 were $6.3 million, an increase of approximately 6% compared to revenues of $5.92 million in the year-ago quarter.

STRM closed Wednesday's trading at $1.54, up 5.48%. In after-hours, the stock was up 6.49% to $1.64.

Zymeworks Inc. (ZYME) (ZYME.TO) has filed a preliminary prospectus supplement for offering of common shares.

The offering is expected to raise total gross proceeds of approximately US$85.0 million. The Company also expects to grant to the underwriters a 30-day over-allotment option to purchase up to an additional 15% of the number of common shares offered in the Offering.

ZYME closed Wednesday's trading at $16.88, down 11.02%. In after-hours, the stock was down 3.44% to $16.30.

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